WO2021198314A1 - Procédé de traitement d'un oedème d'organe interne à l'aide d'un système d'électrode de distribution de courant électrique et système associé - Google Patents

Procédé de traitement d'un oedème d'organe interne à l'aide d'un système d'électrode de distribution de courant électrique et système associé Download PDF

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Publication number
WO2021198314A1
WO2021198314A1 PCT/EP2021/058385 EP2021058385W WO2021198314A1 WO 2021198314 A1 WO2021198314 A1 WO 2021198314A1 EP 2021058385 W EP2021058385 W EP 2021058385W WO 2021198314 A1 WO2021198314 A1 WO 2021198314A1
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Prior art keywords
electrode
internal organ
electrodes
oedema
current
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PCT/EP2021/058385
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English (en)
Inventor
Johannes Müller
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Berlin Heals Gmbh
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Publication of WO2021198314A1 publication Critical patent/WO2021198314A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents

Definitions

  • the present invention relates to a process of treatment of internal organ oedema using an electrical current delivering electrode system comprising two electrodes to be positioned at two places on or close to the internal organ or in liquid carrying vessels as part of the organ or in the internal organ as well as a device for the reduction up to removal of internal organ oedema and a system therefor.
  • organs Primary or secondary disease of an organ, acute or chronic infections or a reduced blood supply to organs are often associated with oedema of the affected organ, which can severely impair the function of the organ. In the heart, this is particularly evident in the form of a restriction of the pumping function, which has an effect on all organs of the body.
  • internal organ oedema relate to myocardial oedema as described in the following prior art articles but also to kidney oedema or liver oedema to name specific internal organs.
  • Reduced pumping function of the heart typically leads to a congestion of blood in other dependent organs (e.g. liver, kidney), which impresses as oedema in these organs.
  • Organ oedema in these organs depends on the severity of the heart dysfunction. Organ oedema can also occur independently of a reduced pumping function of the heart in organ-specific diseases (e.g. diseases of the kidney or liver), such as nephrotic syndrome or inflammation of the liver.
  • organ-specific diseases e.g. diseases of the kidney or liver
  • CMR cardiac magnetic resonance
  • WO 98/23.326 discloses an interferential wave micro current device having a power supply, a frequency generator, a pulse generator, a pulse envelope generator, an electrical current controller, and four or more channels for applying micro amperes of electrical current to patient tissue. Each channel has two electrodes for completing a micro current electrical circuit through patient tissue.
  • the controller provides a controlled amount of current in each channel from about 20 micro amperes to about 200 micro amperes at a frequency up to about 300 Hertz.
  • the device is used to treat lymphedema, edema, fibrosis, and fibro- mylagea by application of interferential wave form micro current on the skin with the discloses electrodes.
  • WO 2017/015714 A1 discloses use of electrical current in a method of reducing lymphoedema in a patient, the method comprising multiple treatment sessions, each treatment session comprising: applying electrical contacts in positions on skin of the patient, configuring the positions to deliver the electrical current to a lymphatic system of the patient associated with a lymphoedema affected region in the patient, configuring the electrical current with a time profile adapted to stimulate the lymphatic system of the patient, and delivering the electrical current through the electrical contacts; the method further comprising scheduling the treatment sessions to occur at least twice per day over most days in each week at least until the lymphoedema is acceptably reduced.
  • the characteristic electrical pulses produced by the units used in the disclosed methods comprise short non- rectangular pulses in the millisecond range separated by gaps in the second range.
  • WO 2017/021255 A2 US 2008/195163 A1 and EP 3 427 789 A1 describe devices and methods for the use of DC electric micro currents for treatment of the human heart.
  • a liquid carrying vessel can be a blood vessel or a vessel of the lymphatic system.
  • the electrodes are positioned on or near by or in the heart at positions taken from the group comprising inside the right ventricle, inside the coronary sinus, on the outside of the left ventricle and/or on the outside of the right ventricle. Regardless of where the electrodes are placed (for example even subcutaneously or outside the human body), it is only relevant that the current flows through the affected organ.
  • the electrode according to the invention for reducing oedema of internal organs through application of an electrical current comprises an electrode support and at least one electrically conductive electrode surface which is embedded in the electrode support, wherein the electrode surface is connected to a control and power supply unit by way of electric lines.
  • the predetermined current density on the electrode can be maintained by controlling/regulating the current or the voltage.
  • the current density can be maintained, in particular, for a time period starting from several minutes up to days, i.e. longer than 24 hours. Subsequently, it is possible but not necessary to provide a direct current having the opposite polarity.
  • the direct current application provides electro-osmosis or an osmotic like effect which generates the secretion of water droplets usually at the cathode, however, depending on the composition of the liquid (electrical charge carriers in the liquid) to be removed, the liquid can also be secreted at the anode.
  • a one-way valve within the patch surface, preferably surrounded by the electrode surface.
  • the fluid is drained at the point where it has the greatest negative influence on the contact between the electrode surface and the surface of the organic tissue.
  • a one-way valve is a diaphragm valve having a valve diaphragm.
  • the process of reduction of the internal oedema applies steps for controlling the current density (J) on the electrode according to the present invention wherein the current (I) flowing through the electrode is regulated in such a way that a current density (J) provided within a predetermined interval for the electrode surface is maintained. Alternatively, the current density (J) is maintained around a predetermined value for the electrode surface.
  • a treatment-specific current density can be set, which is particularly advantageous since providing a predetermined electroosmotic effect.
  • a control unit can achieve that the current density on each electrode part is maintained in such a predetermined interval.
  • Each electrode according to the invention can be used as a current-feeding or current receiving electrode, wherein the cathode is the electrode where the maximum water is gathered and conducted away. Therefore, an important reduction effect of the internal oedema happens where the anode provides the water-reduced area.
  • the process of treatment of internal organ oedema can comprise different current delivering electrode systems.
  • the always comprise two electrodes and a control unit.
  • the two electrodes are to be positioned at two places in relation to the internal organ to be treated and the electrodes are connected to the control unit.
  • the control unit is then adapted to deliver an electric current to induce electro-osmosis.
  • two patch electrodes which can be one-surface electrodes or comprises a plurality of separated segments. Then the patch electrodes are mounted on the outer surface of the internal organ, which can be heart, kidney or liver. Mounted can comprise positioning or attaching. It is also possible to position the patch electrodes just subcutaneously or on the outside of the skin of the patient.
  • a patch electrode is combined with a coil electrode, wherein the patch electrode is positioned on the outer surface of the internal organ, wherein the coil electrode is positioned in a liquid carrying vessel of the internal organ. Then the current is flowing through the organ between the electrode in the blood or lymphatic duct vessel and the outside of the organ.
  • the patch electrode is positioned for the heart on the epicardial side of the heart and wherein the coil electrode is positioned for the heart inside the ventricular cavity.
  • the patch electrode is positioned for the kidney on the outer side opposite to the renal artery and renal vein and wherein the coil electrode is positioned inside the renal artery and renal vein or the renal pelvis.
  • a process of treatment of internal organ oedema can also use two coil electrodes, wherein the two coil electrodes are positioned in different liquid carrying vessels within the same internal organ. Then the current flow is restricted between the core parts of the organ where the coil electrodes are positioned.
  • one of the two coil electrodes can be placed in the coronary sinus and the other of the two electrodes can be positioned in the right or left ventricular cavity.
  • the internal organ oedema to be treated can be a myocardial oedema or an oedema of the kidney or an oedema of the liver.
  • the electro-osmosis is generated for a reduction up to a removal of the internal organ oedema.
  • the electroosmotic effect comprises an accumulation of oedema fluid at the electrodes to be carried away from the electrodes.
  • the current delivered to the electrodes and flowing through the organ can be preferably a direct current.
  • the direct current can be an amplitude modulated direct current, i.e. a direct current wherein the intensity of current is modulated around an average value.
  • the control unit can be configured to switch the polarity of the direct current in predetermined time intervals. Such predetermined time intervals can comprise intervals between 12 hours and 7 days. The entire process can comprise a treatment time of several days up to several months.
  • an electric current flowing between two electrodes is accompanied by electrolysis generating a pH shift in the area of the interface between electrode conducting surface and tissue and creation of gas. Since the current density is small and the electrodes are preferably made of platinum or a platinum iridium alloy, the effects are limited. It is even so that the shift of the pH towards alkaline can have a beneficial effect on the tissue as inflamed tissue often has a pathological pH value.
  • the gas generation is effected at the anode which is preferably in the flowing blood (in the blood vessel) or the flowing lymph fluid (in a lymphatic duct). The liquid is capable to dissolve the gas.
  • the generated gas is especially CI2 which - immediately after its formation, forms bonds that are physiological and therefore harmless.
  • the existence of an electrolysis effect, even if small, is a difference between any application of AC currents to internal organs.
  • the invention further comprises a electrode assembly comprising two electrodes and a control circuit, wherein the first and second electrodes are electrically connected to the control circuit, wherein the control unit is adapted to establish a direct current flow between the first and the second electrode.
  • the electrode assembly has preferably a control unit being adapted to switch the polarity of the current flow between the first and second electrodes.
  • the electrode assembly can comprise two patch electrodes to be positioned opposite one the other of the internal organ so that the current flow between the first and second electrodes is traversing the internal organ.
  • the electrode assembly can have a mixed lay-out with one coil electrode and a patch electrode, wherein the coil electrode is to be positioned inside a liquid vessel of the internal organ and the patch electrode is to be positioned outside of the internal organ so that the current flow between the first and second electrodes is traversing the internal organ oedema part.
  • the electrode assembly can have two coil electrodes to be positioned both inside in different liquid vessels of the internal organ so that the electric current flow between the first and second electrode is traversing through the internal organ oedema part especially between the two liquid vessels.
  • the control unit of the electrode assembly can be adapted to control the strength of the current flowing between the first and second electrodes to control the strength of the electric current flow through the place of the internal organ oedema over time.
  • Myocardial edema the excess accumulation of fluid in the myocardial interstitium, develops when there is an imbalance between filtration from the coronary microvasculature, removal of interstitial fluid via lymphatic vessels, and epicardial transudation. Under pathophysiological conditions, large quantities of proteins accumulate in the interstitial space, producing an osmotic/oncotic sucking force that drives fluid flow into the tissue and prevents fluid absorption back into the circulation. This chain of events creates the essential conditions for the formation of edema.
  • Myocardial edema impairs myocyte contractility and is responsible for systolic and diastolic dysfunction.
  • the fatal feature of myocardial edema formation is that it not only impedes the pumping function of the heart in a purely mechanically fashion but also exerts a proinflammatory effect, induces fibrosis, and stimulates exuberant collagen synthesis in the interstitium by upregulating TGF-beta concentrations.
  • evidence indicates that the excitation- contraction uncoupling induced by myocardial edema causes contractile dysfunction.
  • Experimental removal of edema leads to an immediate improvement in the contractility of the heart.
  • the present invention provides a therapeutic strategy to allow patients to escape the vicious circle of edema, inflammation, and fibrosis associated with the frequently observed decline in cardiac function.
  • the presently disclosed strategy improves lymphatic flow independent of capillary permeability (negatively charged glycocalyx) and pressure conditions (hydrostatic, colloid osmotic) in the capillaries and the interstitium.
  • Electrorheology, electrokinetics, and, in particular, electrophoresis and electroosmosis describe the transport mechanisms of fluids or charged particles, mechanisms that are induced by the application of an electrical field or a direct current, in which an electrical field is inherent.
  • Electrophoresis is well known in medicine as a method of inducing the migration of charged colloidal particles or molecules suspended in a solution by means of an electrical field, with the intention of separating and analyzing them in turn.
  • electrophoresis plays a relevant role in the distribution of molecules.
  • Electroosmosis describes the phenomenon of the movement of a liquid through a capillary vessel bearing a surface charge caused by an electrical field parallel to the surfaces of the vessel. Electroosmotic flow may and will occur through small-channel structures of heterogeneous tissue (such as gap junctions, capillaries, cells, cell membranes, etc.) and can be found in particular in areas of high electrical activity. In addition to the flow generated by pulsatile or osmotic and hydrostatic pressure differences, electrokineticflow is a relevant transport mechanism in even the smallest lymphatic and blood vessels. Thus, edema formation can be interpreted in part as a disturbed electrical environment, inter alia a potential gradient, in the myocardium. This environment includes the negatively charged intraluminal layer (glycocalyx) of the fluid exchange vessels; this layercontrols the permeability of the capillary wall and, in turn, the fluid balance and pressure conditions in the interstitium.
  • Glycocalyx the negatively charged intraluminal layer
  • An externally applied weak electric current as such or together with an electrical field can interrupt the vicious circle of edema formation and impaired cardiac performance. It normalizes the electrical environment with the consequence of increasing lymphatic flow by supporting the electrokinetically induced transport of electroosmosis and electrophoresis and may also influence the charge of the glycocalyx.
  • the ability to determine the extent of myocardial edema by using CMR measurements makes it possible to estimate in advance the degree of rapid cardiac improvement induced by the application of a DC microcurrent over time. This information can be used to stratify patients before implantation of a DC microcurrent device. Patients without myocardial edema will most likely not show a rapid increase in cardiac function immediately after the implantation; they must wait for the anti-inflammatory effect of long-term application of DC microcurrent on myocardial function.
  • the micro current was mentioned to be DC microcurrent.
  • a DC current i.e. having the polarity over at least a minute until hours before a switch of polarity is determined.
  • DC current does not mean constant micro current.
  • the current can be modulated over time, e.g. double in a predetermined time interval and being reduced to the original value in a further predetermined time interval.
  • electroosmotic flow being a known transport mechanism that involves small channel structures of heterogeneous tissue, such as gap junctions or capillaries, and can be found in particular in areas of high electrical activity.
  • One precondition for electroosmotic flow is an electric field parallel to the surface in which the flow should be induced. Therefore, the microvascular fluid balance depends on an intact endogenous electric potential gradient.
  • a disturbed endogenous field leads, via a disturbance of the glycocalyx and electro-osmosis, to a disturbance of the fluid balance and to the formation of myocardial oedema.
  • the rapid effect of microcurrent on cardiac performance is to be derived from the effects of electro-osmosis.
  • the method is based on the insight, that disturbed or absent endogenous electrical fields are being replaced by the external microcurrent at physiological strength.
  • One of the characteristics of electro-osmosis is that it generates measurable effects at the moment the microcurrent is turned on. This characteristic explains why such a rapid effect occurs after the activation of the microcurrent device which will be shown in connection with experiments in connection with embodiments of the invention.
  • Fig. 1 shows a two internal electrode disposition (two internal coil electrodes) of electrodes in the heart as internal organ;
  • Fig. 2 shows a mixed (one internal coil electrode, one external patch electrode) disposition of electrodes in and outside the heart;
  • Fig. 3 shows a two external electrodes (external patches with segmented electrodes) disposition of electrodes on external heart surfaces according to the invention during use;
  • Fig. 4 shows an electrode according to the invention comprising a one-way valve
  • Fig. 5 shows a two external electrodes (external patches with single electrodes) disposition of electrodes on external kidney surfaces according to the invention during use;
  • Fig. 6 shows a mixed (one internal coil electrode, one external patch electrode) disposition of electrodes in and outside the kidney
  • Fig. 7 shows a diagram of experimental data of increase of cardiac activity of a mammal over time in view of the applied microcurrent.
  • Fig. 1 shows a schematic representation of a heart 10 with an electrode assembly 20 according to a first illustrative embodiment of the invention.
  • the implantable direct-current electrode assembly 20 comprises two implantable electrodes 30 and 40 and a control circuit 50, usually arranged in a separate housing in which the battery for the power supply is likewise provided.
  • the two electrodes 30 and 40 are connected to the control circuit 50 via two single conductor cables 51 and 52.
  • the control circuit 50 is designed to establish a potential difference between the two electrodes 30 and 40, such that a direct current can flow between these electrodes 30 and 40.
  • One electrode 30 is a ventricular electrode, provided for positioning in the right ventricle, and is designed as a coil electrode. It is therefore designated below as a ventricular coil electrode 30.
  • the length of the ventricular coil electrode 30, defined by the one conductive metallic sheath surface or coil surface defining a sheath, is ca. 4 to 10 centimeters and is designed to fill as far as possible the entire length of the right ventricle after passage through the right cardiac tricuspid valve.
  • the ventricular coil electrode 30 is placed loosely into the right ventricle, but it can touch the wall of the right ventricle.
  • the electrode To prevent the electrode from falling into the outflow tract of the right ventricle (pulmonary valve), it is anchored actively (by screw) with its tip or passively with barbs in the tip of the right ventricle which hook into the trabecular meshwork of the right ventricle and thus fix the electrode tip.
  • the electrode 30 seems to float freely in the right ventricle. However, this is only apparently the case, because the figures are schematic two-dimensional depictions. Generally, the electrode 30 will nestle on the wall of the ventricle; in the depiction in Fig. 2, this could be the posterior wall, which is not visible there. The electrode 30 is flexible in order to adopt these gentle curvatures, which amount to less than 30 degrees with respect to the longitudinal axis.
  • the other electrode 40 of Fig. 1 is a coronary sinus electrode, provided for positioning in the coronary sinus, and is likewise designed as a coil electrode.
  • This coronary sinus coil electrode 40 has a smaller diameter than the ventricular coil electrode 30 since it is intended to be advanced far into the coronary sinus in order then to come to lie in the narrowing end region there.
  • This electrode thus lies at a position substantially predefined by the vessel walls, which position the operating surgeon otherwise establishes by advancing it in the longitudinal direction.
  • the electrode 30 can be the cathode for a predetermined time of between a few minutes and up to chronically, whereby the direction of the current is predefined.
  • the control circuit can then change the direction of the current after a correspondingly predetermined time, whereby the electrode 40 becomes the cathode.
  • the current strength can also change, since the resistance between the two electrodes 30 and 40 is dependent on the direction of the current.
  • control device controls the current strength at a uniform predetermined value.
  • the DC current can have a constant value or can be amplitude modulated with a modulation height of e.g. +-10% to +-25% of the average DC value.
  • Fig. 2 shows a schematic representation of a heart 10 with an electrode assembly 120 according to a second illustrative embodiment of the invention.
  • the implantable direct- current electrode assembly 120 comprises two implantable electrodes 30 and 140 and also a control circuit 50.
  • the control circuit 50 can be designed in the same way as described in Fig. 1.
  • the two electrodes 30 and 140 are also connected to the control circuit 50 via two single-conductor cables 51 and 52.
  • the control circuit 50 is also designed here to establish a potential difference between the two electrodes 30 and 140, such that a direct current can flow between these electrodes 30 and 140 for a predetermined time of several minutes, e.g. 5 minutes, to several days, e.g. 3 days or even chronically.
  • One electrode 30 is once again a ventricular electrode, provided for positioning in the right ventricle, and is designed as a coil electrode. It is therefore also designated here as a ventricular coil electrode 30.
  • the length of the ventricular coil electrode 30, defined by the one conductive metallic sheath surface or coil surface defining a sheath, is ca. 4 to 10 centimeters and is designed to fill as far as possible the entire length of the right ventricle in the longitudinal axis after passage through the right cardiac valve (tricuspid valve).
  • the ventricular coil electrode 30 is placed loosely into the right ventricle, is passively anchored at the distal end and can bear on the wall of the ventricle or on the septum. To prevent the electrode from falling into the outflow tract of the right ventricle (pulmonary valve), it is anchored actively (by screw) with its tip or passively with barbs in the tip of the right ventricle.
  • the other electrode 140 is a surface electrode (patch electrode), provided for positioning on the epicardium, the pericardium or close to the epicardium (e. g. even subcutaneously). It can be designed, for example, according to the teaching of US 2008/0195163 A1. This surface electrode 140 is applied to the left side of the myocardium, epicardially opposite the right ventricle.
  • a direct current then flows according to the arrows 155 through the myocardium.
  • This flow of current is symbolized here by two arrows which essentially show the approximate current flow direction, since the flow of current here fans out from a substantially longitudinally dimensional face of the substantially longitudinally oriented surface of the coil electrode 30 toward the surface electrode 140 and thus sweeps across a fan.
  • the direct current flows through a prism; that is to say proceeding from an edge (of the prism) to its base on the patch electrode.
  • a prism is by definition a geometric body whose side edges are parallel and of equal length and which has a polygon as base. It arises from parallel displacement of a plane polygon along a straight line not lying in this plane and is therefore a special polyhedron.
  • the straight line is predefined by the longitudinal axis of the coil electrode 30, and the polygon is a triangle with the apex at the coil electrode 30 and with a base that corresponds to the width of the surface electrode (patch electrode) 140. If these side edges 141 of the surface electrode 140 do not come to lie parallel to the orientation of the coil electrode, it is a rotated prism.
  • the two electrodes 30 and 140 define a not inconsiderable spatial body which guarantees that the direct current emitted by the control circuit 50 flows through a likewise not inconsiderable sub region of the left cardiac muscle and to a slightly lesser extent also of the right cardiac muscle.
  • Describing the geometry of the body through which the current flows as a prism is an approximation, since it can be assumed from this that the electrode does not float freely but is instead passively fixed at its distal tip and then bears on the wall of the ventricle.
  • the boundary lines of the body are then certainly not straight but curved, and the defined body is then obtained only approximately as a prism. Of importance, however, is the narrow "edge" on the one side formed by the coil electrode, and the "broad bottom face" on the other side which is formed by the patch electrode.
  • Fig.3 shows two patch electrodes 240 and 340 which are connected with lines 51 and 52 to a control and power supply unit 50.
  • each patch electrode 240 and 340 as such is a segmented electrode 240 or 340.
  • each electrode 240 or 340 is or comprises a plurality of electrode segments 241 or 341 which are shown as smaller rectangles in Fig. 3.
  • an electrode surface of a patch electrode 240 or 340 which is 100 square centimeters in size in total, and a direct current I of 1 milliampere, the current density is 0.01 milliamperes per square centimeter. If the electrode surface (here a plurality of the electrode segments 241 or 341 detaches from the tissue, e.g.
  • the organ 10 can be a heart, it is also possible that the organ 10 is a kidney with applied electrodes 240 and 340. In other embodiments it could be a liver.
  • the electrode 1 optionally comprises at least one one-way valve 70 which essentially comprises an opening 72 and a diaphragm 73 covering the opening 72 on the far side of the internal organ.
  • a schematic sectional view of the one-way valve 70 is depicted in Fig. 4.
  • the diaphragm is made from silicone, for example.
  • the one-way valve 70 is situated within the electrode surface 75.
  • the apparatus as described in connection with Fig. 1, 2 or 3 delivers an electric current, e.g. a direct current, to the internal organ, here the heart.
  • This electric current e.g. a direct current, acts immediately or at least extremely fast on the internal organ, here the heart.
  • the electric current mainly causes ion movement (electrokinesis), i.e. the migration of negatively charged anions (e.g. CI-, CO2- etc.) to the anode and of positively charged cations (e.g. Na+. Mg++.etc.) to the cathode.
  • Electro-chemical reactions occur on metals (electrodes, but also metallic foreign bodies).
  • a migration of protein fractions (electrophoresis) and a shift of water in the direction of the cathode (electro-osmosis) takes place in the applied direct current field.
  • the effect is as such independent from the application with two internal coil electrodes, one coil electrode and one patch electrode or two patch electrodes applied on opposite parts of the internal organ like the on the left and the right ventricle.
  • FIG. 1 Although the drawings only show the heart in the application, similar coil electrodes can be used for the treatment of a liver and/or a kidney.
  • The can be used in blood vessels or the lymphatic system.
  • Flat electrodes can be positioned on or near the liver or kidney with the flat electrodes on mainly opposite sides of the organ, so that the current passes through the organ. This can also be done subcutaneously or from the exterior of the human body.
  • Fig. 5 shows a two external electrodes (external patches with single electrodes) disposition of electrodes on external kidney surfaces according to the invention during use.
  • kidneys 11 with a symbolic central aorta or vena renalis 13.
  • Ureters 12 connect the kidneys 11 with the bladder of the person.
  • a patch electrode 440 is positioned on the outside of one kidney 11.
  • a second patch electrode 440' (with an identical outlay to the first patch electrode 440) is positioned on the opposite side of the kidney 11. Therefore, the core part of the kidney with its renal pyramids 17, renal calix 16 and the renal pelvis 18 is positioned between the two patches 440 and patches 440'.
  • the flat electrode patches 440 and 440' are connected with a control unit 50, not shown in Fig. 5, via connection lines 51 and 52, respectively.
  • the supply lines 51 and 52 provide a current flow between the flat electrode patches 440 and 440' which current then effectively flows through the mentioned parts of the kidney to reduce the oedema through electro osmotic effects.
  • the electrode patches 440 and 440' are shown as single electrodes but can also be segmented electrodes as shown in Fig. 3.
  • Fig. 6 shows a mixed (one internal coil electrode, one external patch electrode) disposition of electrodes in and outside the kidney.
  • the kidney 11 is shown with its renal pyramids 17, renal calix 16 and the renal pelvis 18.
  • the aorta renalis 14 and vena renalis 15 are shown as well.
  • a first external electrode 440 is connected via line 51 to a control unit 50 (not shown).
  • a renal coil electrode 540 is positioned in the vena renalis 15 to allow a current flow between this electrode 540 and said external patch electrode 440.
  • the connection of the renal coil electrode 540 to the control unit 50 is effected via the catheter line 53 used to position the renal coil electrode 540.
  • the coil electrode could in other embodiments also positioned in the renal lymphatic system.
  • Fig. 7 shows a diagram of experimental data of increase of cardiac activity of a mammal over time in view of the applied microcurrent.
  • the time interval shown in Fig. 7 on the X- axis as time 600 extends over three hours.
  • the thick line shows the applied DC microcurrent 610 over time 600. If on the left of the diagram the y-axis reference numeral 611 indicates the value of the applied microcurrent, it is given between 0 and at the top 7000 microampere, so the maximum current value 612 applied was 3072 microampere.
  • the thin line shows the averaged cardiac output value 620 If on the right of the diagram the y-axis reference numeral 621 indicates the value cardiac output in liter/min, the values are between 5 and 6 liter/min with the bottom line 622 of the cardiac output of the mammal before the application of the current at about 5.4 liter/min. The dots show the different measurements over time.
  • the acute experiment was performed on a healthy sheep with open chest.
  • a first value 613 of 183 microampere of electrical microcurrent was applied directly to the heart via two electrodes.
  • cardiac output (CCO) increased as the first improvement 623 shows in proportion to the increase in the level of the microcurrent, and this increase was also proportional to an increase in the strength of the electrical field.
  • a reduction down to 40 microampere was made in a second time interval.
  • An increase to 409 microampere as third value 614 was made in a third time interval.
  • Finally the value was ramped up to above mentioned maximum value 612 with a corresponding CCO improvement as the line 624 shows.

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  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un procédé de traitement d'œdème d'un organe interne utilisant un système d'électrodes (50) délivrant un courant électrique (155) comprenant des électrodes (30, 140) à positionner à deux endroits sur la surface externe de l'organe interne et/ou dans un récipient transportant un liquide de l'organe interne et délivrant un courant électrique pour induire une électro-osmose entre les électrodes (30, 140). Un système d'assemblage d'électrodes pour ce traitement par électro-osmose comprend à proximité des deux électrodes (30, 140) une unité de commande (50) adaptée pour commander le flux de courant entre les deux électrodes (30, 140).
PCT/EP2021/058385 2020-03-30 2021-03-30 Procédé de traitement d'un oedème d'organe interne à l'aide d'un système d'électrode de distribution de courant électrique et système associé WO2021198314A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998023326A1 (fr) 1996-11-27 1998-06-04 Suzuki James Y Dispositif multicanal micro-courant a onde d'interferences, et technique de traitement par micro courant
US20080195163A1 (en) 2005-04-06 2008-08-14 Friederike Scharmer Electromedical Implantable or Extracorporeally Applicable Device For the Treatment or Monitoring of Organs, and Method For Therapeutic Organ Treatment
WO2017015714A1 (fr) 2015-07-27 2017-02-02 Bodyflow International Pty Ltd Traitement de lymphœdème primaire ou secondaire
WO2017021255A2 (fr) 2015-07-31 2017-02-09 Berlin Heals Holding Ag Ensemble d'électrodes à courant continu implantable
EP3427789A1 (fr) 2017-07-11 2019-01-16 Berlin Heals Holding AG Ensemble d'électrodes à courant continu implantables

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998023326A1 (fr) 1996-11-27 1998-06-04 Suzuki James Y Dispositif multicanal micro-courant a onde d'interferences, et technique de traitement par micro courant
US20080195163A1 (en) 2005-04-06 2008-08-14 Friederike Scharmer Electromedical Implantable or Extracorporeally Applicable Device For the Treatment or Monitoring of Organs, and Method For Therapeutic Organ Treatment
WO2017015714A1 (fr) 2015-07-27 2017-02-02 Bodyflow International Pty Ltd Traitement de lymphœdème primaire ou secondaire
WO2017021255A2 (fr) 2015-07-31 2017-02-09 Berlin Heals Holding Ag Ensemble d'électrodes à courant continu implantable
EP3427789A1 (fr) 2017-07-11 2019-01-16 Berlin Heals Holding AG Ensemble d'électrodes à courant continu implantables

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* Cited by examiner, † Cited by third party
Title
FREDERIK H. VERBRUGGE ET AL.: "Global myocardial oedema in advanced decompensated heart failure", EUROPEAN HEART JOURNAL - CARDIOVASCULAR IMAGING, vol. 18, 2017, pages 787 - 794
MAEKAWA HTODA G, NIHON RINSHO, vol. 63, no. 1, 2005, pages 80 - 84
MATTHIAS G. FRIEDRICH, WHY EDEMA IS A MATTER OF THE HEART, Retrieved from the Internet <URL:http://circimaging.ahajournals.org>
RANJEET M. DONGAONKAR ET AL.: "Myocardial microvascular permeability, interstitial oedema, and compromised cardiac function", CARDIOVASCULAR RESEARCH, vol. 87, 2010, pages 331 - 339
SIDDALL ECRADHAKRISHNAN J.: "The pathophysiology of edema formation in the nephrotic syndrome", KIDNEY INT, vol. 82, no. 6, 2012, pages 635 - 642
THOMAS M. GORTER: "Myocardial oedema and congestive heart failure: one piece of the puzzle? Reply", EUROPEAN JOURNAL OF HEART FAILURE, 2018, pages 827 - 828

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